A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

Recruiting now · Phase 2

Conditions studied: Advanced Solid Tumors, HER2 Mutation

In brief

Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers want to learn how well BAY2927088 (sevabertinib) works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the breast, the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC). Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer. The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth. The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial. During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.

Key facts

Study ID: NCT06760819
Run by: Bayer
People needed: 111
Starts: 2025-02-13
Expected to finish: 2027-10-25
Last updated by the study team: 2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer; bladder and urothelial tract cancer; cervical cancer; endometrial cancer; breast cancer; other solid tumor cancer, excluding NSCLC)
Participant must be ≥18 years of age or over the legal age of consent
Patients who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments
Documented activating HER2 mutation
At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria

You may not qualify if…

Primary diagnosis of non-small cell lung cancer (NSCLC)
Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)
Active brain metastases
Uncontrolled, severe, intercurrent illness

Where it is running

Odense University Hospital | Svendborg Sygehus - Oncology Department — Odense, Region Syddanmark, Denmark (enrolling)
Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus — Fort Myers, Florida, United States (enrolling)
Dana-Farber Cancer Institute - Oncology Department — Boston, Massachusetts, United States (enrolling)
UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital — Birmingham, Alabama, United States (enrolling)
Profound Research -OMG - TriAtria Cancer Center — Farmington Hills, Michigan, United States (enrolling)
Cleveland Clinic - Oncology Department — Cleveland, Ohio, United States (enrolling)
SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
The University of Texas MD Anderson Cancer Center - Texas Medical Center — Houston, Texas, United States (enrolling)
City of Hope - Duarte Cancer Center — Duarte, California, United States (enrolling)
UW Health Carbone Cancer Center — Madison, Wisconsin, United States (enrolling)
NSW Health - Blacktown Hospital — Blacktown, New South Wales, Australia (enrolling)
Macquarie University Hospital - Oncology Department — Sydney, New South Wales, Australia (enrolling)
ICON Cancer Centre - Southport — Southport, Queensland, Australia (enrolling)
Queen Elizabeth II Health Sciences Centre | Oncology — Halifax, Nova Scotia, Canada (enrolling)
Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology — Toronto, Ontario, Canada (enrolling)
McGill University Health Centre - Glen Site - Women Health's Research Unit — Montreal, Quebec, Canada (enrolling)
Peking University First Hospital - Oncology Department — Beijing, Beijing Municipality, China (enrolling)
Beijing Cancer Hospital - Oncology Department — Beijing, Beijing Municipality, China (enrolling)
Hunan Cancer Hospital - Oncology Department — Changsha, Hunan, China (enrolling)
Fudan University Shanghai Cancer Center - Oncology Department — Shanghai, Shanghai Municipality, China (enrolling)
Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department — Hangzhou, Zhejiang, China (enrolling)
Rigshospitalet Copenhagen University Hospital | Oncology Department — Copenhagen, Capital Region, Denmark (enrolling)
Aarhus University Hospital | Oncology Department - Clinical Research Unit — Aarhus N, Central Jutland, Denmark (enrolling)
Centre Hospitalier Lyon Sud - Service oncologie medicale — Pierre-Bénite, Auvergne-Rhône-Alpes, France (enrolling)

Full record on ClinicalTrials.gov

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